A multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa linked to artificial tears has grown to 68 patients in 16 states, with three deaths, eight reports of vision loss and four patients requiring surgical removal of an eyeball, according to federal and state public-health investigations.

The outbreak is especially concerning because the strain carries resistance mechanisms rarely seen together in the United States. The Centers for Disease Control and Prevention first alerted clinicians in a February health advisory that it was investigating infections associated with multiple artificial-tear products, with EzriCare Artificial Tears the brand most commonly reported by patients.

A rare resistance profile raises the stakes

The organism is a Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase-producing carbapenem-resistant P. aeruginosa, often shortened to VIM-GES-CRPA. CDC said the outbreak strain had not previously been reported in the United States before this investigation. Carbapenem-resistant Pseudomonas can be difficult to treat because the bacteria are naturally resistant to some antibiotics and can acquire additional resistance mechanisms.

Cases have involved infections of the cornea, respiratory tract and urinary tract as well as colonization without symptoms. The serious eye outcomes have focused attention on the way a contaminated product placed directly onto the ocular surface can create a route for infection, particularly among people with underlying eye disease or other vulnerabilities.

Federal regulators acted in early February. The Food and Drug Administration warned consumers not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears because of potential bacterial contamination. FDA cited manufacturing concerns involving Global Pharma Healthcare, including current good manufacturing practice issues and the formulation and testing of a multidose product sold without preservatives.

A nationwide recall followed

Global Pharma Healthcare subsequently issued a nationwide recall of all lots within the expiration dates of EzriCare and Delsam Pharma Artificial Tears distributed in the United States. The recall notice advised consumers to stop using the products and seek medical care if they experienced signs of infection.

The investigation has relied on patient interviews, product testing, microbiology and genomic analysis. CDC reported finding the outbreak strain in opened bottles collected from patients. Testing of sealed products and manufacturing samples has been part of the continuing effort to determine whether contamination occurred during production or after bottles were opened.

By this week, the scale of the outbreak had increased materially from the numbers reported in the original February alert. Fortune reported the updated federal count of 68 patients, three deaths and severe eye injuries, highlighting how quickly what began as an unusual cluster had become a national product-safety event.

Vision loss makes the outbreak unusually severe

The eye-related consequences distinguish this episode from many contaminated consumer-product recalls. The Philadelphia Inquirer reported that eight patients had lost vision and four had undergone enucleation, or surgical removal of an eyeball. Those outcomes reflect the potential for aggressive bacterial keratitis and deeper infection to destroy ocular tissue despite treatment.

The same organism can produce serious systemic illness in medically vulnerable people. Pseudomonas aeruginosa is an opportunistic pathogen commonly associated with healthcare settings, devices, wounds and people with weakened defenses. Its capacity to survive in moist environments makes contamination of liquid products particularly important from an infection-control perspective.

Public-health officials have emphasized that patients who used recalled drops should watch for eye pain or discomfort, redness, blurred vision, sensitivity to light, discharge or a sensation that something is in the eye. Clinicians have been asked to consider the outbreak strain in patients with compatible infections and to report cases through public-health channels.

Manufacturing controls are under scrutiny

The outbreak also raises broader questions about sterile-drug manufacturing. Ophthalmic products must be manufactured under controls designed to prevent microbial contamination because they are applied to tissues that can be damaged rapidly by invasive organisms. FDA’s warning identified concerns involving manufacturing practices and the use of a multidose bottle without an adequate preservative system.

Contemporaneous coverage by Ars Technica described the resistance pattern as particularly alarming and noted that investigators were still working to establish the precise source of contamination. Forbes likewise reported the updated toll and the unusual combination of deaths, vision loss and eye removals.

The immediate public-health message remains straightforward: consumers should not use the recalled EzriCare or Delsam Pharma artificial tears, and symptomatic patients should seek medical evaluation promptly. But the larger implications extend beyond one brand. The investigation will test whether regulatory inspections, sterile manufacturing standards, supply-chain oversight and adverse-event surveillance can identify and contain risks before a resistant organism is distributed widely through a product intended for routine home use.

For clinicians, the outbreak is also a reminder that resistance patterns can transform ordinarily manageable infections into medical emergencies. With 68 patients already identified across 16 states, federal agencies are continuing case finding and laboratory work. The final extent of the outbreak is not yet known, making continued reporting, product tracing and microbiologic surveillance essential.